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Sleep and Light Therapy for Circadian Rhythm Disorder (CARRS-P2 Trial)
N/A
Recruiting
Led By Brant Hasler, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuously up to every 6 months for up to 5 years
Awards & highlights
CARRS-P2 Trial Summary
This trial will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs.
Who is the study for?
This trial is for healthy teens typically enrolled in high school, who go to bed later than 11:15 PM and are not homeschooled. They can't have metal in their body, be pregnant, have unstable medical conditions, recent changes to psychotropic meds, extreme late sleep patterns, frequent headaches or migraines, a history of substance use or serious psychiatric disorders.Check my eligibility
What is being tested?
The study explores how manipulating sleep and circadian rhythms affects reward function in adolescents. It involves monitoring sleep patterns and mood while adjusting light exposure (more bright light in the morning; less blue light at night) and managing sleep schedules.See study design
What are the potential side effects?
There may be no direct side effects from the interventions since they involve non-invasive techniques like adjusting light exposure and modifying sleep schedules. However, changing one's routine could temporarily affect mood or alertness.
CARRS-P2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ continuously up to every 6 months for up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuously up to every 6 months for up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Circadian alignment at 2 weeks
Change from baseline in Sleep timing at 2 weeks
Change from baseline in behavioral inhibition at 2 weeks
+4 moreSecondary outcome measures
Caffeine use
Substance use
CARRS-P2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Advance/Extend ManipulationExperimental Treatment4 Interventions
For ~2 weeks, Advance/Extend participants will advance bedtime and regularize wake time. The first night of the manipulation will be conducted in the lab under tightly-controlled experimental conditions. Participants will then go home and for the next 12 days will be instructed to:
Sleep scheduling-- advance bedtime by 1.5 hours ( + sleep duration)
Decrease evening blue light exposure via blue blocker goggles (2 hrs before bed)
Increase morning bright light exposure via bright light goggles (30 min after rise)
Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
Group II: ControlActive Control1 Intervention
Control participants will complete the baseline laboratory study, then maintain their habitual sleep schedules over the next 13 days at home, with no instruction on sleep timing or light exposure. Control participants will complete smartphone-and text-based assessments, thereby controlling for effort.
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,309 Total Patients Enrolled
University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,846 Total Patients Enrolled
Brant Hasler, PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe or unstable health conditions.You have a serious mental health condition, like depression or bipolar disorder, that could make it hard for you to finish the study.You have used alcohol, cannabis, or illegal drugs in the past month, or more than once a month in the past year.I am enrolled in a traditional high school with live classes.I am in good physical and mental health.A close family member has bipolar disorder.I do not have any sleep disorders needing ongoing treatment.I have a history of seizures.I often experience headaches or migraines.I haven't changed my mental health medications in the last 2 weeks.I have a sleep disorder that is not insomnia or delayed sleep phase disorder.I am not taking medications that increase sensitivity to light.You should not have other sleep disorders that cause a lot of problems, according to specific criteria in the Sleep SCID.You usually go to bed later than 11:15 PM.
Research Study Groups:
This trial has the following groups:- Group 1: Advance/Extend Manipulation
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has the capacity to partake in this trial?
"This clinical trial is recruiting 100 adolescents between the ages of 13 and 15 with delayed sleep phase syndrome. Those hoping to be admitted must meet a set of criteria, such as being enrolled in traditional high-school learning (excluding cyber or home schooling; although school closures due to COVID are an exception), demonstrate good physical and mental health, provide written consent/assent from guardians if applicable, and have bedtimes after 11:15PM for those assigned to the experimental protocol."
Answered by AI
How many individuals are currently participating in this clinical trial?
"That is correct. According to the data hosted on clinicaltrials.gov, this medical trial first appeared on May 1st 2021 and was recently updated as of August 1st 2022. It requires 100 individuals from a single location."
Answered by AI
Is the eligibility criteria of this clinical trial inclusive to individuals over 65 years old?
"This clinical study is open to participants between the ages of 13 and 15."
Answered by AI
Is this analysis currently open to recruitment?
"Affirmative. According to the data hosted on clinicaltrials.gov, this medical experiment is currently recruiting patients; it was originally posted on May 1st 2021 and last updated on August 1st 2022. The study necessitates 100 volunteers from a single site for participation."
Answered by AI
Who else is applying?
What site did they apply to?
Western Psychiatric Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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